Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
21.17 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
Overall assessment factor (AF):
7.5
Modified dose descriptor starting point:
NOAEC
DNEL value:
158.8 mg/m³
Explanation for the modification of the dose descriptor starting point:

According to scientific opinion of the European Food Safety Authority (EFSA Journal 2004, 112: 1-10), calcium sulfate is approved as a food additive by JECFA and SCF with an ADI not allocated. They also stated that the oral intake of up to 1062 mg/person/day (which is equal to 15.2 mg/kg bw/day for a 70 kg person) would not result in any adverse effects. Therefore, this value of 15.2 mg/kg bw/day can be regarded as NOAEL for long-term oral uptake. Assuming that inhalation uptake is at best equal to oral bioavailability, this oral NOAEL can be converted to a NOAEC of 158.8 mg/m³ following the ECHA Guidance R.8, taking into account exposure duration (8h work shift), human bodyweight (70 kg) and breathing volume (20 m³/24h).

AF for interspecies differences (allometric scaling):
1.5
Justification:
Assessment factor for correction of worker breathing volume correction
AF for intraspecies differences:
5
Justification:
Default for workers
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5 082 mg/m³
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
Overall assessment factor (AF):
7.5
Modified dose descriptor starting point:
NOAEC
DNEL value:
38 115 mg/m³
Explanation for the modification of the dose descriptor starting point:

According to scientific opinion of the European Food Safety Authority (EFSA Journal 2004, 112: 1-10), calcium sulfate is approved as a food additive by JECFA and SCF with an ADI not allocated. They also stated that, assuming a worst case scenario, the one-time oral intake of up to 8000 mg/person/day (which is equal to 114 mg/kg bw/day for a 70 kg person) would not result in any adverse effects. Therefore, this value of 114 mg/kg bw/day can be regarded as NOAEL for short-term oral uptake. Assuming that inhalation uptake is at best equal to oral bioavailability, this oral NOAEL can be converted to a NOAEC of 38113 mg/m³ following the ECHA Guidance R.8, taking into account exposure duration (15 min), human bodyweight (70 kg) and breathing volume (20 m³/24h).

AF for interspecies differences (allometric scaling):
1.5
Justification:
Assessment factor for correction of worker breathing volume correction
AF for intraspecies differences:
5
Justification:
Default for workers

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5.29 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
Overall assessment factor (AF):
10
Modified dose descriptor starting point:
NOAEC
DNEL value:
52.9 mg/m³
Explanation for the modification of the dose descriptor starting point:

According to scientific opinion of the European Food Safety Authority (EFSA Journal 2004, 112: 1-10), calcium sulfate is approved as a food additive by JECFA and SCF with an ADI not allocated. They also stated that the oral intake of up to 1062 mg/person/day (which is equal to 15.2 mg/kg bw/day for a 70 kg person) would not result in any adverse effects. Therefore, this value of 15.2 mg/kg bw/day can be regarded as NOAEL for long-term oral uptake. Assuming that inhalation uptake is at best equal to oral bioavailability, this oral NOAEL can be converted to a NOAEC of 52.9 mg/m³ following the ECHA Guidance R.8, taking into account exposure duration (24h), human bodyweight (70 kg) and breathing volume (20 m³/24h).

AF for intraspecies differences:
10
Justification:
Default for general population
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3 811 mg/m³
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
Overall assessment factor (AF):
10
Modified dose descriptor starting point:
NOAEC
DNEL value:
38 113 mg/m³
Explanation for the modification of the dose descriptor starting point:

According to scientific opinion of the European Food Safety Authority (EFSA Journal 2004, 112: 1-10), calcium sulfate is approved as a food additive by JECFA and SCF with an ADI not allocated. They also stated that, assuming a worst case scenario, the one-time oral intake of up to 8000 mg/person/day (which is equal to 114 mg/kg bw/day for a 70 kg person) would not result in any adverse effects. Therefore, this value of 114 mg/kg bw/day can be regarded as NOAEL for short-term oral uptake. Assuming that inhalation uptake is at best equal to oral bioavailability, this oral NOAEL can be converted to a NOAEC of 38113 mg/m³ following the ECHA Guidance R.8, taking into account exposure duration (15 min), human bodyweight (70 kg) and breathing volume (20 m³/24h).

AF for intraspecies differences:
10
Justification:
Default for general population

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.52 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
Overall assessment factor (AF):
10
Modified dose descriptor starting point:
NOAEL
DNEL value:
15.2 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

According to scientific opinion of the European Food Safety Authority (EFSA Journal 2004, 112: 1-10), calcium sulfate is approved as a food additive by JECFA and SCF with an ADI not allocated. They also stated that the oral intake of up to 1062 mg/person/day (which is equal to 15.2 mg/kg bw/day for a 70 kg person) would not result in any adverse effects. Therefore, this value of 15.2 mg/kg bw/day can be regarded as NOAEL for long-term oral uptake.

AF for intraspecies differences:
10
Justification:
Default for general population
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
11.4 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
Overall assessment factor (AF):
10
Modified dose descriptor starting point:
NOAEL
DNEL value:
114 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

According to scientific opinion of the European Food Safety Authority (EFSA Journal 2004, 112: 1-10), calcium sulfate is approved as a food additive by JECFA and SCF with an ADI not allocated. They also stated that, assuming a worst case scenario, the one-time oral intake of up to 8000 mg/person/day (which is equal to 114 mg/kg bw/day for a 70 kg person) would not result in any adverse effects. Therefore, this value of 114 mg/kg bw/day can be regarded as NOAEL for short-term oral uptake.

AF for intraspecies differences:
10
Justification:
Default for general population

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population